A Target Occupancy Study With Ritlecitinib.

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Pfizer
Study ID
NCT05128058
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a phase 1, open label, two-arm study to assess target occupancy and functional inhibition of JAK3 and TEC kinases by Ritlecitinib in healthy adult participants

Key Dates

Start date
Oct 22, 2021
Status verified
Nov 2023
Primary completion
Jan 14, 2022
Completion
Jan 14, 2022

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohort 1
    Subjects will be dosed with 50 mg Ritlecitinib on Day 1 and followed up till Day 3
  • Experimental: Cohort 2
    Subjects will be dosed with 200 mg Ritlecitinib on Day 1 and followed up till Day 3

Primary Outcome Measure

Percent Target Occupancy for JAK3 [ Time Frame: -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Pfizer Clinical Research Unit - New HavenNew HavenConnecticut06511-

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Pfizer Clinical Research Unit - New Haven· New Haven, CT

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